The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults

University of Colorado Boulder (CU)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Aging

Treatments

Behavioral: Time Restricted Feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT02970188

15-0108

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of time-restricted feeding (eating within an 8-hour window) for improving physiological function (vascular, motor, cognitive and metabolic function) in healthy middle-aged and older adults.

Full description

Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Enrollment

12 estimated patients

Sex

All

Ages

55 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Ability to provide informed consent
Baseline brachial flow-mediated dilation (FMD) < 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.

Exclusion criteria

Ages <55 years or ≥80 years
Occupation that requires night-shift work or abnormal hours that would disrupt eating schedule
Dietary habit of regularly skipping meals, already eating within a ~10 hour window, or any other form of restrictive eating.
Unable to adhere to an 8 hour eating window for the length of the study period
Participation in regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week)
Not weight stable in the prior 3 months (>2 kg weight change).
Body mass index (BMI) >40 kg/m^2 (rationale: vascular function measurements can be inaccurate in severely obese subjects)
Current smoking
Diagnosis of a chronic clinical disease (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia.
Having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto- coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or change in medication and/or dosage within 3 months prior to enrollment.
Having thyroid disease that is not controlled by medications or <3 month's use of a particular medication and/or dosage (rationale: uncontrolled thyroid diseases are associated with alterations in vascular function).
Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders